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RETIN-A (TRETINOIN) CREAM, GEL, LIQUID: PRESCRIBING INFORMATION
Retin-A Cream, Gel, and Liquid, containing tretinoin are used for the topical treatment of acne vulgaris.
Retin-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butyl alcohol, hydroxypropyl cellulose and alcohol (denatured with tertbutylated
hydroxytoluene, and brucine sulfate) 90% w/w.
Retin-A (Tretinoin) Cream contains tretinoin in either of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, polyoxyl 40 stearate, isopropyl myristate, stearyl alcohol, sorbic acid, xanthan gum, butylated hydroxytoluene, and purified water.
Retin-A Liquid contains tretinoin 0.05% by weight, polyethylene glycol 400, butylated hydroxytoluene and alcohol (denatured with tert-butyl alcohol and brucine sulfate) 55%.
Chemically, tretinoin is all-trans-retinoic acid.
Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation.
Additionally, Tretinoin (Retin-A) stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
INDICATIONS AND USAGE
Retin-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.
Gels are flammable. Avoid fire, flame or smoking during use.
Keep out of reach of children.
Keep tube tightly closed.
Do not expose to heat or store at temperatures above 120°F (49°C).
Retin-A nonclinical toxicology
USE IN SPECIAL POPULATIONS
Retin-A use in special populations
The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of Retin-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with Retin-A (Tretinoin) gel, cream, and liquid. To date, all adverse effects of this medication have been reversible upon discontinuance of therapy.
If Retin-A (Tretinoin) cream, gel and liquid is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
DOSAGE AND ADMINISTRATION
Retin-A dosage and administration
HOW SUPPLIED / STORAGE
Retin-A (Tretinoin) is supplied as:
Retin-A Cream 0.025% 20g and 45g
Retin-A Cream 0.05% 20g and 45g
Retin-A Cream 0.1% 20g and 45g
Retin-A Gel 0.025% 15g and 45g
Retin-A Gel 0.1% 15g and 45g
Retin-A Liquid 0.05% 28 ml
Retin-A Liquid, 0.05%, and RETIN-A Gel, 0.025% and 0.01%: store below 86°F.
Retin-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.
Manufactured and distributed by Janssen, Ortho-McNeil Pharmaceutical companies and their divisions.
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